18 results · 23ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Radiology

RHEAD

FDA UDI
Stryker GmbH·00886385023694·Radial Broach Assy; Size 2

PRECISION ONE LIFECARE; DETECTO; DETECTO

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODIFICATION TO SYNTHES MATRIX SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

25 GA POSTERIOR WIDE-FIELD ELITE PACK

FDA Adverse Event
Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

BRAVO

FDA Adverse Event
Malfunction ·GIVEN IMAGING·Product code FFT·July 12, 2011

CONSULTA CRT-D

FDA Adverse Event
Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 14, 2014

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 10, 2020

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

FDA Adverse Event
Injury ·SYNTHES USA·Product code NKB·January 18, 2016

BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 9, 2020

PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 9, 2020

5.5MM TI CURVED ROD 45MM

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

FDA Enforcement
Class II ·Terminated·Cook Inc.·September 23, 2020

Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021